1 Scope
This document specifies the framework and the methodology to evaluate and demonstrate
the applicability of a validated non-animal method from an OECD test guideline to
assess the skin sensitizing potential of a medical device or a medical device
material. This document addresses:
-
— the database of reference chemical skin sensitizers and non-skin
sensitizers;
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— reference materials;
-
— feasibility testing of candidate test methods, including
any method optimization for use with extracts of medical devices;
-
—
prevalidation of candidate test methods;
-
— the interlaboratory
study:
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— sample preparation and coding;
-
— spiking of the extracts from the negative control medical device
material;
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— data collection;
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— statistical analysis to assess reliability and reproducibility.
The use of the approaches described in this document to assess the applicability of
a
candidate test
method does not imply that the candidate test method
can be used as a stand-alone test for evaluating the skin sensitization potential
of
medical devices. For certain candidate test methods, integrated
approaches and/or defined approaches are needed.[1] The evaluation of skin sensitization
potential of a medical device is described in ISO 10993‑10.